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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HD111680-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| TriHealth Inc. | OTHER |
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The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are:
Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI?
Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing.
Participants will:
This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions.
The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS).
An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration.
This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lingual Endurance Exercise | Experimental | The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing, and re-evaluated every 2 weeks, for each participant. |
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| Sham Exercise | Sham Comparator | The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotonic Endurance Exercise | Behavioral | Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) | MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure. | Change from Baseline (at the end of 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngeal Swallow Efficiency | Measurements via the ASPEKT method (Analysis of Swallowing Physiology: Events, Kinematics, and Timing) will be analyzed to compared pre and post treatment swallow efficiency. The amount will be presented as a percent of anatomical C2-C4 Scalar. Higher percentile, in general indicated greater impairment, however these will be compared to published normative data for reference. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fractional anisotropy (FA) | Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter. | Change from Baseline (at the end of 8 weeks) |
| Change in cortical thickness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Hopkins, MS | Contact | +1 513 558 4152 | hopkiak@ucmail.uc.edu | |
| Rebecca Reinert | Contact | +1 513 558 1719 | gibsonrk@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brittany N Krekeler, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45220 | United States |
There is not a plan currently to share IPD with other researchers.
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Randomized Sham Controlled
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| Sham Exercise | Behavioral | Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day |
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| Change from Baseline (at the end of 8 weeks) |
| Penetration Aspiration Scale (PAS) Scores | 8-point rating scale that is used to capture both degree and sensation of penetration and aspiration. | Change from Baseline (at the end of 8 weeks) |
| Adherence | number of repetitions attempted/total number of repetitions prescribed | At the end of 8 weeks |
| Pharyngeal Swallow Safety | Closure above the airway must be achieved for swallowing safety and in a timely manner. The ASPEKT method (Analysis of Swallow Physiology: Events, Kinematics and Timing) will be used to analyze changes of laryngeal vestibule closure pre and post treatment. | Change from Baseline (at the end of 8 weeks) |
| Maximum Isometric Pressure imaging with video-fluoroscopy | Maximum isometric press will be recorded in kPa and with recorded imaging using video-fluoroscopy. This will be collected pre- and post-therapy to determine any changes in oropharyngeal movements with a lingual press. | Change from Baseline (at the end of 8 weeks) |
| Dietary Intake (Average Daily Calorie Intake) Outcome | A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess average daily energy (kJ) intake over 3 days | Change from Baseline (at the end of 8 weeks) |
| Food Textures Consumed Outcome | A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess the relative percentage (%) of dry texture food intake, on average, across three days | Change from Baseline (at the end of 8 weeks) |
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter. |
| Change from Baseline (at the end of 8 weeks) |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |